Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist

Other Name: Brand: Dormire (Cristalia, Sao Paulo, Brazil)

Placebo Comparator: placebo

placebo oral syrup twenty minutes before starting the procedure

Drug: Placebo

Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Other Name: Magistral formula

Detailed Description:

This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:

oral midazolam + oral ketamine + inhaled sevoflurane

oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.

Eligibility

Ages Eligible for Study:

2 Years to 5 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion Criteria:

Children presenting with at least one of the following:

airway obstruction and/or oral breathing;

recent use of systemic corticosteroids

needing less than two dental restorations;

previous dental sedation.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01795222